Renalytix has announced that the US Food and Drug Administration (FDA) has granted De Novo marketing authorisation for its KidneyIntelX.dkd prognostic test for chronic kidney disease (CKD). This, the company says in a press release “affirms KidneyIntelX as a first-in-class, artificial intelligence enabled prognostic testing platform to guide care management” for adults with type 2 diabetes and early-stage diabetic CKD. It adds that it believes FDA authorisation will lead to increasing test adoption, informing clinical guidelines, expanding insurance coverage, and pursuing additional international regulatory approvals.
“Meeting the rigorous safety, clinical and analytical validation, and scientific data requirements of an FDA review, from Breakthrough Device designation to De Novo marketing authorisation, is a landmark event for health care providers and patients with diabetic kidney disease,” says James McCullough, CEO of Renalytix. “With this approval a new class, Prognostic Test for Assessment of Chronic Kidney Disease Progression, has been established by the FDA, providing a roadmap for future expansion of KidneyIntelX into new indications and products.”
KidneyIntelX.dkd stratifies patients into three risk levels (low, moderate, and high). This result provides “comprehensive information on patient risk” for progressive decline in kidney function within five years independently, the press release states, of current standard of care measures. KidneyIntelX.dkd is the name used to differentiate tests to be provided under the De Novo marketing authorisation by the FDA from those provided under the KidneyIntelX name as a Laboratory Developed Test (LDT).
Since being introduced as a LDT, KidneyIntelX results have been reported on approximately 10,000 patients in the United States and there has been broad insurance payment including from Medicare and many private payers. The KidneyIntelX platform, the company says, combines blood-based biomarkers with clinical variables using an artificial intelligence enabled algorithm, providing “reliable and actionable information to guide care in large, at-risk patient populations”. KidneyIntelX is based on technology developed at the Icahn School of Medicine at Mount Sinai (New York, USA) and licensed to Renalytix.